- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03127085
A.Fib Emergency Department Study Atrial Fibrillation
Patient Specific Reasons for Attending the Emergency Department in the Setting of a Background History of Atrial Fibrillation
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
This study is a multi-centre, multi-provincial, patient survey using mixed methods. 778 patients will be enrolled from 9 centres in 3 provinces from academic, urban, and rural centres to achieve geographical and health system heterogeneity. The planned duration of the entire study (enrollment through follow-up) is approximately 12 months. Patients presenting to the ED with a primary diagnosis of AF and with a prior diagnosis of established AF will be approached to participate. Each centre will be responsible for obtaining local consent. Data will be stored confidentially and securely at the coordinating centre (Queens University, Kingston, Ontario).
Patients who meet the inclusion criteria will be invited to take part at the time of presentation to the ED or after their ED visit. For all enrolled patients, one follow up telephone call will be made within one to four weeks of the ED visit by a social scientist with specialised training in questionnaires based in Queens University, Kingston, Ontario.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Ontario
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Kingston, Ontario, Canada, K7L 2V7
- Kingston Health Sciences Centre - Kingston General Hospital Site
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Male or female ≥ 18 years of age
- Atrial fibrillation is the primary reason for ED visit (documented by 12-lead ECG or Holter rhythm strip by a member of the healthcare team providing care to the patient).
- Patients with an established history of AF (prior diagnosis with ECG / rhythm strip evidence of AF)
- Patient must be literate in English
- Patient must provide informed consent
Exclusion Criteria:
- Male or female < 18 years of age
- Non-English speaking
- unable and/or unwilling to consent
- Acute coronary syndrome (ischemic chest pain, ST changes, + troponin [mild troponin elevation alone does not exclude the patient])
- Cardiogenic shock or class IV congestive heart failure at the time of visit
- Enrolled in a cardiovascular drug or device research study
- New onset atrial fibrillation
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Patient decisions and perceptions before an after attending the emergency department with symptoms which may be related to atrial fibrillation
Tidsramme: All surveys will occur within a time period of less than or equal to four weeks post emergency department visit
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A detailed telephone survey will be performed in which patients with a known history of atrial fibrillation and symptoms which they feel are related to their diagnosis and who are agreeable to take part in the study will be called by a social scientist.
They will be asked a series of questions and their responses will be recorded either on a Likert scale (symptom severity, satisfaction with treatment, quality of life) or as qualitative data (exact symptoms, fears and concerns relating to their underlying diagnosis)
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All surveys will occur within a time period of less than or equal to four weeks post emergency department visit
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Benedict Glover, MD, Queen's University
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AF ED
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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Kliniske forsøg med Atrieflimren
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W.L.Gore & AssociatesAfsluttetSeptal defekt, atrialForenede Stater
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Pusan National University HospitalIkke rekrutterer endnuHjerteimplanterbar elektronisk enhed | Atrial High Rate EpisodeKorea, Republikken
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W.L.Gore & AssociatesAfsluttetSeptal defekt, atrialForenede Stater
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Academisch Medisch Centrum - Universiteit van Amsterdam...Tilmelding efter invitationKortkoblet idiopatisk ventrikulær fibrillationHolland
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Henry Ford Health SystemTrukket tilbage
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Centre Hospitalier Universitaire, AmiensHenri Mondor University HospitalRekrutteringSeptisk chok | Kritisk pleje | Transthorax ekkokardiografi | Speckle Tracking | Reproducerbarhed | Venstre atrial belastning | Højre atrial belastning | Ekkokardiografisk softwareFrankrig
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Assiut UniversityTrukket tilbageASD2 (Secundum atrial septal defekt)
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First Affiliated Hospital of Ningbo UniversityAfsluttetEvaluering af radiofrekvensoverført punkteringssystem | Atrial septum punkteringKina
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Prof. Dr. med. Ingo EitelRekrutteringAtrial hypertensionTyskland
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Nobles Medical Technologies II IncTilmelding efter invitationForamen Ovale, Patent | Septal defekt, atrial | Septaldefekt, HjerteForenede Stater, Italien